Method of manufacturing mouth guard having internal components for sensing impact forces

ABSTRACT

A mouth guard senses impact forces and determines if the forces exceed an impact threshold. If so, the mouth guard notifies the user of the risk for injury by haptic feedback, vibratory feedback, and/or audible feedback. The mouth guard system may also remotely communicate the status of risk and the potential injury. The mouth guard uses a local memory device to store impact thresholds based on personal biometric information obtained from the user and compares the sensed forces relative to those threshold values. The mouth guard and its electrical components on the printed circuit board are custom manufactured for the user such that the mouth guard provides a comfortable and reliable fit, while ensuring exceptional performance.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority to provisional patentapplication titled “Impact Sensing Mouth Guard and Method” filed Dec.20, 2018 and assigned Ser. No. 62/782,965, which is incorporated hereinby reference in its entirety.

COPYRIGHT

A portion of the disclosure of this patent document may contain materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patentdisclosure, as it appears in the Patent and Trademark Office patentfiles or records, but otherwise reserves all copyright rights whatsoever

FIELD OF THE INVENTION

The present invention relates generally to wearable devices for thedetection of injurious concussive forces. More particularly, thisinvention relates to a mouth guard with on-board electronics for sensingexternal impact forces, transforming such data, communicating risklevels locally to the user and remotely to other devices.

BACKGROUND OF THE INVENTION

At all levels, athletics are seen as constructive methods of exercise.Sports encourage robust competition and health. Men, women, boys, andgirls participate in a variety of sports and athletic activities on aformal and informal basis. Given the variety of individuals involved,there is a large number of activities and sports played by many diverseplayer types. Some games involve high-speed running. And some involvemore physical sports with purposeful or incidental contact betweenplayers and/or fixed objects. Contact raises the potential for harm,including head and brain injury. While American football is seen as aprimary cause of sports concussions and long-term brain injury, it isless known that players in other sports also experience a high-risk forhead injury and brain trauma. For instance, the incidence of concussionsin girls' soccer is second only to football, and the combined incidenceof concussions for boys' and girls' soccer nearly matches that offootball.

Virtually any forceful impact to the head or body involves some risklevel for brain trauma. Head injury may occur from collision withanother player, an object, or even from a fall. Impact and rotationalforces to the head are the leading causes for injury. Brain injurymanifests as either neural, or most often, vascular injury within thehead.

It is also widely known that the risk and severity of brain injury isrelated to the frequency and severity of repeated head trauma. A firstblow to the head may modify the risk factors for future injury. Forinstance, a first incidental hit may lower the threshold for injury dueto a later fall to the ground. Repeated blows and impacts have a greaterimpact on the risk of head trauma. Even a minor blow, below the normalthreshold for injury, may cause catastrophic brain injury if it followsan earlier risk-elevating first impact. Furthermore, biometricinformation (i.e., sex, age, height, weight, etc.) provides anadditional factor that is needed to determine the impact threshold forpredicting brain injury for a particular individual.

During sports play, head injury may manifest as a temporary impairmentor loss of brain function. However, more severe concussions may cause avariety of physical, cognitive, and emotional symptoms. Unfortunately,some injuries cause no immediate or obvious observable symptoms, andeven minor symptoms may be overlooked, especially during the excitedflow of a game. The unknown consequences of prior impacts furtherexacerbate the risks, by failing to diagnose an injury and takecorrective action.

In recent studies, the CDC estimates that about 40% to 50% of athleteswill not self-report that they may have suffered a concussive blow.While some portion of these athletes who fail to report head injuriesare likely out of stubbornness, the failure to report is oftenattributed to the player not experiencing traditional or expectedconcussion symptoms. Consequently, notifying the user that he or she hasreceived a significant impact (or impacts) is necessary for the user toreport the event.

Considering the high-risk of injury in various sports and activities(such as personal fitness programs), prior art solutions have notprovided a solution that is flexible and precise enough for use in themyriad of routines for the entire spectrum of athletes. For instance,given the extent of electronics and monitoring systems required for headinjury assessment tools, products to be worn by players often involve askull cap or complete helmet. A helmet, while welcomed in permissivecontact sports such as football, hockey and motocross, might beout-of-place for tennis, interfere with play for a sport such as soccer,and even presents an added danger on the rugby pitch. Furthermore, priorart solutions have traded accuracy for comfort, or otherwise required acomprise sacrificing either the usefulness of information or wearingcompliance with the user.

Other products include multiple part pieces that are deployed atdifferent parts of the player's body and can be cumbersome and/orcomplicated to employ. Additionally, other solutions do not provide asimple, customizable, single-piece portable solution.

Clinical tests have proven that the combined measurement of linear andangular acceleration has the most accurate prediction of concussionpossibilities, compared to either of the measurements independent of oneanother. Clinical studies suggest that sensors located in a mouth guard,as opposed to an accessory on a helmet or a chinstrap, have a highercorrelation to the center of gravity of the brain. This is thought to bea result of the mouth guard's placement in relation to the rear molars,which are attached to the base of the skull. Certain anatomicallandmarks on the head, such as in the inner ear, are considered by someto be effective in correlating impacts to brain injury. However, due tothe size and quantity of the components required to ensure properdetection, as well as the relative locations of components, the spatialarrangement and structure of such devices have been unable to achieve auseful device that is ergonomically acceptable and a comfortable fit forthe user.

The present invention resolves many of these issues by providing a mouthguard that reliably identifies impact forces that may cause a headinjury and notifies the user of that impact event. The inventive mouthguard is not only customizable to the user and is comfortable to wear,but is constructed through a simplistic manufacturing process.

All these and other objects of the present invention will be understoodthrough the detailed description of the invention below.

SUMMARY OF THE INVENTION

The present invention is directed to an impact sensing device and systemfor communicating information about impacts and user status. A mouthguard vibrates, creates a tone, sends a local signal, and/or otherwiseindicates the impact to the user. In one embodiment, a piezoelectricvibration may create a tone that is only audible to the wearer via boneconduction.

In one aspect, the present invention is a mouth guard for measuringimpact forces and determining possible concussive risk and brain injury.The mouth guard device is able to detect and measure the impact force toan athlete's head during activities by use of an array of motion andaccelerometer sensors. The mouth guard preferably contains a sensorarray, a battery, a (wireless) power receiver with charging circuit,communications system (such as a Bluetooth low-energy transceiver), amechanical indicator (e.g., piezo transducer), and a light indicator(e.g., an RGB LED indicator). The sensors are designed to measure force,and correlate such forces with predetermined impact thresholds,preferably for linear and angular forces. Preferably, thosepredetermined impact thresholds may be later modified automaticallywhile the user is participating in the activity in response to one ormore impacts to the head. The system is also capable of determiningimpacts caused when the device is worn in place, as opposed to impactswhen the device is being handled in other manners (e.g., when the userdrops the mouth guard). The electrical components are provided on aflexible printed circuit board (PCB) that is configured to have a lowprofile that provides user comfort, despite being embedded within themouth guard. The mouth guard may be charged by a wireless powertransmitter that sources power from a standard USB power adapter.

Regarding notification of an impact, the mouth guard may provide theuser with local and/or remote notification. Local notification mayinclude a notification component (e.g., piezoelectric, haptic, and/ormagnetic device) that operates to create an audible tone (e.g., 2-4 kHz)that is conducted generally along the bone and skull. Local notificationmay include an audible tone, bone conduction signal, vibration, and/orother haptic feedback. Additionally, a local notification may include alight indication (e.g., LED) on the mouth guard of a certain colorand/or pattern representing the level of risk and/or injury, which maybe noticed by other individuals (e.g., referees, coaches, other players,etc.) who see the light indicator in the mouth guard of the user. Ofcourse, the user who removes the mouth guard will notice the lightindicator as well. The light may be turned off, leaving a local and aremote notification in place. Remote location may be sent viatelecommunication to a remote receiver, such as a smart phone, with asoftware application prepared to receive incoming information anddisplay to a remote user. Multiple wearable devices may each be assignedto separate users, and the remote receiver may manage signals frommultiple devices, such as a coach of a team simultaneously monitoringeach individual player during a practice session or game.

In another aspect, the inventive mouth guard system for detection impactforces comprises a main body, at least one sensor, and a notificationcomponent. The main body comprises flexible material and has a frontportion with a generally arched-shaped peripheral side for facing thebuccal region of a mouth of a user. The main body further includes adepressed portion adjacent to the front portion that is sized and shapedto receive teeth of the user. The at least one sensor detects a forceand is embedded in the flexible material. The at least one sensor islocated within the front portion. The notification component is embeddedwithin the flexible material and generates mechanical energy. Thenotification component activates in response to the at least one sensordetecting a force above a predetermined force threshold.

In another aspect, the inventive mouth guard system comprises main body,a printed circuit board, a processor, a linear force sensor, arotational force sensor, and a notification component. The main body iscomprised of flexible material and has a front portion with a generallyarched-shaped peripheral side for facing the buccal region of a mouth ofa user. The main body further includes a depressed portion adjacent tothe front portion that is sized and shaped to receive teeth of the user.The printed circuit board is embedded within the flexible material inthe front portion and extends along a substantial portion of thearched-shaped peripheral side. The processor is located on the printedcircuit board. The linear force sensor and the rotational force sensorare located on the printed circuit and are in communication with theprocessor. The notification component generates mechanical energy and islocated on the printed circuit board. And, wherein, in response to atleast one of the linear sensor and the rotational sensor detecting aforce above a predetermined force threshold, the processor activates thenotification component to produce a feedback to be sensed by the user.

In yet a further aspect, the present invention is a method forindicating a high impact force to a user wearing a mouth guard. Themethod comprises detecting at least a first impact event with at leastone of a linear force sensor and a rotational force sensor embedded inthe mouth guard, and determining whether a force associated with thefirst impact event exceeds a predetermined threshold. The method furtherincludes, in response to the force exceeding a predetermined threshold,generating mechanical energy with a notification component to inform theuser that the predetermined threshold has been exceeded. Thenotification component is embedded within the mouth guard and provide atleast one of a haptic feedback, a vibratory feedback, or an auditoryfeedback to the user.

In yet another aspect, the present invention relates to a mouth guardsystem for detection impact forces. The mouth guard system includes amain body and a printed circuit board. The main body is comprised offlexible material and has a front portion with a generally arched-shapedperipheral side for facing the buccal region of a mouth of a user. Themain body further includes a depressed portion adjacent to the frontportion that is sized and shaped to receive teeth of the user. The frontportion includes a centerline to be located generally adjacent to theincisors and two ends to be located generally adjacent to the right andleft molars. The printed circuit board is embedded within the flexiblematerial in the front portion of the main body and has a lengthextending along a substantial portion of the arched-shaped peripheralside. The printed circuit board includes a front side facing toward thebuccal region of the mouth and a back side facing toward the teeth ofthe user. The printed circuit board includes components for detectingand indicating an impact force above a predetermined threshold. Thecomponents include at least a processor, a memory device, a forcesensor, a battery, and a light indicator. The light indicator is locatedon the front side of the printed circuit board at the center of thefront portion and is activated in response to an impact force exceedinga predetermined threshold. The force sensor is located on the back sideof the printed circuit board near the center of the front portion of themain body. The processor and memory device are located on the back sideof the printed circuit board. The battery is located on the front sideof the printed circuit board adjacent to one of the ends.

In another aspect, a mouth guard system for detection of impact forcescomprises a main body and a printed circuit board. The main bodycomprises a flexible material and has a front portion with a generallyarched-shaped peripheral side for facing the buccal region of a mouth ofa user. The main body further includes a depressed portion adjacent tothe front portion that is sized and shaped to receive teeth of the user.The front portion includes a center to be located generally adjacent tothe incisors and two ends to be located generally adjacent to the rightand left molars. The printed circuit board is embedded within theflexible material in the front portion of the main body and has a lengthextending along a portion of the arched-shaped peripheral side. Theprinted circuit board includes a front side facing toward the buccalregion of the mouth and a back side facing toward the teeth of the user.The printed circuit board includes components for detecting andindicating an impact force above a predetermined threshold. Thecomponents include at least a processor, a memory device, a first forcesensor, a second force sensor, a battery, and an indicator foractivation in response to an impact force exceeding the predeterminedthreshold. The printed circuit includes a middle portion with a lengththat is at least about 25% of the overall length of the printed circuitboard. The middle portion has a width in the range of 6 mm to 15 mm andincludes two cut-outs to enhance the bendability of the printed circuitboard. The processor, the memory device, the first force sensor, and thesecond force sensor are mounted in the middle portion.

In yet another aspect, the invention relates to a method formanufacturing a custom mouth guard that detects impact forces of a user.The method comprises conforming a first layer of material to a model ofthe user's maxillary region that includes replicated teeth and, whilethe first layer of material is on the model and after the conforming,heating the first layer of material. The method further includes forcinga flexible printed circuit board into the heated first layer to force aplurality of components extending away from the flexible printed circuitboard to be impressed into the first layer. The flexible printed circuitboard includes linear and rotational force sensors. The method alsoincludes overlaying a second layer of material over the flexible printedcircuit board and the first layer, and conforming the second layer ofmaterial to exposed surfaces of the flexible printed circuit board andthe first layer to create the custom mouth guard.

In another aspect, the invention is a method for manufacturing a custommouth guard that detects impact forces of a user. The method comprisesreceiving biometric information associated with the user and storingimpact threshold data on a memory of a flexible printed circuit board.The impact threshold data is based on the biometric information. Themethod further includes, after the receiving and the storing, conforminga first layer of material to a model of the user's maxillary region thatincludes replicated teeth. The method also includes forcing the flexibleprinted circuit board into the first layer to impress electricalcomponents on the flexible printed circuit board into the first layer,and conforming the second layer of material to exposed surfaces of theflexible printed circuit board and the first layer to create the custommouth guard.

In yet another aspect, the invention includes a method for manufacturinga custom mouth guard that detects impact forces of a user. The methodcomprises receiving a stone model of the user's maxillary region thatincludes replicated teeth, and receiving biometric information for theuser. The biometric information at least includes the age and sex of theuser. The method includes determining impact threshold data for the userbased on the biometric information, and uploading the impact thresholddata onto a memory device that is mounted on a flexible printed circuitboard. The flexible printed circuit board has other components mountedthereon including a linear force sensor, a rotational force sensor, aprocessor, and a battery. The method further includes conforming a firstlayer of material to the stone model of the user's maxillary region, andwhile the first layer of material is on the model, heating the firstlayer of material. The method also includes forcing the flexible printedcircuit board into the heated first layer to force a plurality of thecomponents from the flexible printed circuit board to be impressed intothe heated first layer, and conforming a second layer of material toexposed surfaces of the flexible printed circuit board and the firstlayer. The conforming includes impressing some of the components on theprinted circuit board into the second layer of material.

Additional aspects of the invention will be apparent to those ofordinary skill in the art in view of the detailed description of variousembodiments, which is made with reference to the drawings, a briefdescription of which is provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described with greater specificity andclarity with reference to the following drawings, in which:

FIG. 1 illustrates a perspective view of the back side of a flexibleprinted circuit board assembly of an embodiment of the presentinvention;

FIG. 2 illustrates a perspective view of the front side of the flexibleprinted circuit board assembly of FIG. 1;

FIG. 3 illustrates one embodiment of a cross-sectional view of theprinted circuit board used in the flexible printed circuit boardassembly of FIG. 1;

FIG. 4A illustrates a left side profile view of the flexible printedcircuit board assembly along the 4A-4A line in FIG. 1;

FIG. 4B illustrates a right side profile view of the flexible printedcircuit board assembly along the 4B-4B line in FIG. 1;

FIG. 5 illustrates a schematic of the components of the flexible printedcircuit board assembly of FIG. 1 according to one embodiment;

FIG. 6A illustrates a user's stone model that replicates his or hermaxillary region and associated dentition, which is used in the processof manufacturing the inventive mouth guard;

FIG. 6B illustrates overlaying a first layer over the user's stone modelin the process of manufacturing the mouth guard;

FIG. 6C illustrates embedding the flexible printed circuit boardassembly of FIGS. 1-2 in the first layer that overlays the user's stonemodel in the process of manufacturing the mouth guard;

FIG. 6D illustrates overlaying a second layer over the first layer andthe embedded flexible printed circuit board assembly in the process ofmanufacturing the mouth guard;

FIG. 7 illustrates the finished mouth guard from the manufacturingprocess of FIGS. 6A to 6D; and

FIG. 8 illustrates a graphical user interface on a mobile device thatprovides an indication of impacts for multiple users of the mouth guard.

While the invention is susceptible to various modifications andalternative forms, specific embodiments will be shown by way of examplein the drawings and will be described in detail herein. It should beunderstood, however, that the invention is not intended to be limited tothe particular forms disclosed. Rather, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE DRAWINGS

The drawings will herein be described in detail with the understandingthat the present disclosure is to be considered as an exemplification ofthe principles of the invention and is not intended to limit the broadaspect of the invention to the embodiments illustrated. For purposes ofthe present detailed description, the singular includes the plural andvice versa (unless specifically disclaimed); the words “and” and “or”shall be both conjunctive and disjunctive; the word “all” means “any andall”; the word “any” means “any and all”; and the word “including” means“including without limitation.”

A mouth guard 1, shown best in FIG. 7, includes a flexible printedcircuit board (PCB) and electronic components mounted thereon, whichdefine a printed circuit board assembly (PCBA) 2. The PCBA 2 is designedand shaped for placement within the mouth guard 1, which is custom-fitfor an athlete's mouth. The electronic components are encased within theflexible material of the mouth guard 1. The PCBA 2 is also flexible anddesigned with minimal structural dimensions (length, height, width,depth, etc.) for flexing and pivoting to conform to the contours of themouth guard 1 during manufacturing and use. In one aspect, the inventionherein focuses on the novel arrangement of the electronic components onthe PCBA 2 to achieve efficient manufacturing, excellent operationalperformance, and user comfort.

The mouth guard 1 can detect and measure impacts to an athlete's headduring sports activities. An array of motion and accelerometer sensors(discussed below) detect and measure an acceleration on the user, whichcan then be calculated into force data. The impact data is stored on themouth guard and may be later or contemporaneously transmitted via atransmitter (e.g., a Bluetooth low energy transceiver) to a remote smartdevice, such as a phone or tablet, or like device (see FIG. 8).Additional information regarding the mouth guard is disclosed inco-owned U.S. Publication No. 2017/0238850 (“Impact Sensing WearableDevice and Method”), which is hereby incorporated by reference in itsentirety.

As can be seen in FIG. 1, the PCBA 2 has a length that is definedbetween two end portions 3 that are intended to rest along the buccalside of the molars. The PCBA 2 includes a front side 4, which will facethe buccal region of the wearer after incorporation in the mouth guard1, and a back side 6 that will face the teeth. A middle portion 7 of thePCBA 2 is positioned between the two end portions 3 and generally has alength between about 25% and 50% of the overall length of the PCBA 2.The electrical components are primarily mounted within the middleportion 7. In one preferred embodiment, the middle portion 7 is about40% of the overall length of the PCBA 2.

A center tab 11 is located within the middle portion 7 and is positionedin the front center of the mouth near the midline of the user'sincisors. The center tab 11 is defined by a pair of cutouts 12 thatprovide the middle portion 7 with the ability to twist and bend asrequired during fabrication of the mouth guard 1, as discussed belowwith respect to FIG. 6. As such, the cutouts 12, which allow for dualaxis rotation and twisting at pivot points adjacent thereto, allow thePCBA 2 to overcome the challenges of conforming within the custom mouthguard 1. The two cutouts 12 have a length that is at least 30% of theoverall width of the middle portion 7. The middle portion 7 requires theadditional bendability because it will be located along the regionhaving the smallest radius of curvature in the dental arch (and, thus,in the mouth guard 1). The bridge portions 16, 17 of the PCBA 2 connectthe end portions 3 and the middle portion 7 and are created by largercut-outs to create a smaller dimension within the bridge portions 16, 17for enhanced bendability of the PCBA 2.

The components are preferably soldered onto PCBA 2 and an underfill(preferably a non-viscous epoxy) is used to fill in spaces within thePCBA 2 to provide some level of rigidity to the PCBA 2. The electricalcomponents on the PCBA 2 are preferably attached with minimal solder.The largest dimension of each of the electronic components is verticallyoriented when possible to accommodate bending of the PCBA 2, meaning thelong edge is arranged from top-to-bottom while the short edge runslaterally along the length of the PCBA 2. Some components cannot bevertically oriented, such as a wireless charging receiver 20 and abattery 22, and, thus, are preferably placed near the end portions 3 ofthe PCBA 2, which will be placed along an anatomic region having alarger radius of curvature (i.e., straighter) than the middle portion 7.The PCBA 2 is preferably made of a multilayered board design to act asprimary carrier of all electronic components in the mouth guard 1, asdiscussed below with reference to FIG. 3.

The wireless charging receiver 20 is set on the front side 4 of the PCBA2. As shown in FIG. 2, the wireless charging coil 21 is set opposite toa charging receiver 20. The charging receiver 20 includes power circuitwith inductors and capacitors, and further includes an integratedcircuit controller located in proximity to and in electricalcommunication (e.g., wired) with the wireless charging receiver 20. Thewireless charging receiver 20 and the wireless charging coil 2 arepreferably set along on of the molar ends 3 and configured to bestreceive the energy from the external charging station (not shown). Assuch, the charging coil 21 may be manipulated during the manufacturingprocess (FIG. 6) to ensure proper positioning so as to minimize skewingrelative to the peripheral side surface of the mouth guard 1 that facesthe buccal surface.

Regarding the force-sensing components, the PCBA 2 includes a high-G(high-gravity) accelerometer 30, a magnetometer 31 (which includes adigital compass), and a combination low-G (low gravity)accelerometer/gyroscope 32. The magnetometer 31 and the combinationlow-G (low gravity) accelerometer/gyroscope 32 form an inertialmeasurement unit (IMU) in that they provide data that is used forsensing the orientation of the mouth guard 1. The data provided by theIMU is utilized in a sensor-fusion algorithm, which is computed in theprocessor to implement a sensing feature that detects the orientation ofthe PCBA 2 and the mouth guard 1 in three-dimensional space. Thecombination low-G (low gravity) accelerometer/gyroscope 32 (hereinafter“gyroscope 32”) can also be provided as two separate components, suchthat they are not packaged together. Alternatively, the magnetometer 31can be packaged with the low-G (low gravity) accelerometer/gyroscope 32.The gyroscope 32 also provides data regarding angular velocity, whichcan be used to determine the angular acceleration (and rotational force)associated with the impact. Though these sensors 30, 31, 32 aremeasuring velocity and acceleration, they are herein considered to belinear and rotational force sensors because their sensed data correlatesto the corresponding force and permits the processor to calculate it, asnecessary.

The approximate location of the impact is computed using the IMUorientation result at the time of the impact and a calculated 3D linearacceleration impact vector. The 3D linear acceleration impact vector(relative to the mouth guard 1) is calculated using the data collectedby the high-G accelerometer 30 at the moment of impact. In summary, thedata received by the high-G accelerometer 30, the magnetometer 31, andthe low-G accelerometer/gyroscope 32 can be used to provide informationregarding the amount of linear force associated the impact, the amountof rotational force associated the impact, the spatial orientation ofthe impact, and movement data of the user.

Data from the high-G accelerometer 30, the magnetometer 31, and thegyroscope 32 is received and processed in a processor 28, which utilizesa memory 34 (preferably a flash memory) to correlate, relate, andotherwise store information for processing and communicating impactdata. The memory 34, which may store impact data permanently or beerasable, may be located anywhere on the PCBA 2, but is preferably nearthe processor 28 to minimize latency. The processor 28 is furthercoupled with low energy Bluetooth transceiver 29. The Bluetoothtransceiver 29 may include a radio and an embedded processor. Theprocessor 28 collects data, stores the data in memory 34, and transmitsthe data via Bluetooth transmission, as necessary. It should beunderstood that while a single memory 34 is illustrated on the PCBA 2,it may have multiple memory devices 34. For example, the processor 28may include its own memory device.

A serial wire debug (SWD) port 18 on the PCBA 2 allows wired access forinitial programming of the processor(s) 28. In one embodiment, theinitial programming data, such as impact thresholds based on thebiometric data of the user, are stored in a memory device associatedwith the processor 28, while the impact data received by the sensingcomponents is stored in the memory 34 showing in FIGS. 1-2. The usertypically provides his or her biometric data when ordering the custommouth guard 1. The biometric data of the user may include, but is notlimited to: age, sex, weight, height, skull circumference, head shape(e.g., from photos of the sides, back, and/or front of the head), headmass (e.g., from a scan of the head), and/or prior concussion data. Thebiometric data may further include dimensional data taken from themaxilla of the user, such as from a stone model as discussed below withrespect to FIG. 6. For example, the combination of the skullcircumference along the forehead and the dimensional data of the maxillaprovide s data that correlates to the mass of the head. Alternatively, astandard mass of the head may be estimated based on the age, sex,weight, and/or height of the user using commonly known biometricinformation. Assuming that standard mass is known, it can then beadjusted based on measurements of the specific measurements of theuser's skull and/or maxilla data. In other words, a user having a skullcircumference that is 10% larger than the standard skull circumferencefor someone of his same age, weight, and height may have the standardmass increased by 5% due to the larger-than-standard skullcircumference. Examples of linear and rotational force risk factors andthreshold data for different individuals are disclosed in co-owned U.S.Publication No. 2017/0238850 (“Impact Sensing Wearable Device andMethod”), which is hereby incorporated by reference in its entirety.

The biometric data of the user is used to set initial thresholds forimpact forces (e.g., rotational forces and/or linear forces). Inaddition to establishing a single maximum threshold over which the riskof a concussion is high, the impact thresholds may include aseries-based threshold that takes into account a series of impact eventsover a certain period of time. The series-based threshold would indicatethe risk of concussion due to a series of smaller impact forces(relative to the single maximum threshold) encountered over a period oftime. For example, the series-based threshold can be based on a weightedaverage of the hits, wherein the threshold (as measured by the weightedaverage) is reduced based on the number of hits. The rate of change inthe reduced threshold force may be linear or exponential. Theseseries-based thresholds are a form of dynamic thresholds, in that theychange during a session (e.g., a game) of the user's activity, or overmultiple sessions of activities. It should be understood that the user'sprior concussion history (both short term, such as the impacts occurringover a 24-hour period, or long term, such as a prior concussion withinthe last two months) is also biometric data of the user that can be usedto establish the thresholds. These different initial thresholds valuesand dynamic threshold values for the user may be stored in variouslook-up tables in the memory of the PCBA 2 within the mouth guard 1.And, as discussed below in FIG. 8, they may be modified over the courseof operation of the mouth guard 1 by the smart device 50.

The user can also indicate different activities for which he or sheintends to use the mouth guard 1. For example, a user may indicate thatshe intends to use the mouth guard for boxing and soccer. Each of theseactivities may have different impact threshold data that will be storedon the memory device of the PCBA 2 due to the different types of impactforces and frequency of impact forces that are anticipated. Some of thedifferences may be due to the sensitivity of the impact forces to bedetected by the sensors on the PCBA 2. As one example, boxing may havehits that are longer in duration due to the deformation of the boxinggloves, whereas an undesirable head-to-head impact in a soccer match canbe of very short duration. Additionally, boxing regulations may restrictcertain hits, such as a hit to the back of the head. Because the mouthguard 1 can sense the directionality of hits, a hit to the back of thehead in a boxing match, regardless of force, may cause the LED 10 toactivate to inform the boxers (and referee) that a restricted hitoccurred. Accordingly, the inventive mouth guard 1 may include impactthreshold data (e.g., different look-up tables) for multiple activitiesof the user. The user would use a smart device (e.g., mobile phone 50 inFIG. 8) to communicate the specific activity chosen for that particularday (or session) to the mouth guard 1 via the Bluetooth connection. Theprocessor 28 then pulls the corresponding impact threshold data storedwithin the memory device for the user's chosen activity and uses thatimpact threshold data for comparisons during the activity. It should benoted, as explained above, that two different users participating in thesame two activities will still have different impact threshold data foreach activity (e.g., boxing look-up table #1, soccer look-up table #1,boxing look-up table #2, soccer look-up table #2) because of theirdifferent biometric information. Accordingly, the user's indication ofhis or her activity or activities (not just biometric information) mayalso dictate the types of impact force threshold data that are stored inthe memory of the PCBA 2.

The various impact thresholds for the user and potentially other datauseful for determining concussion risk can be uploaded to one of thememory devices via the SWD debug port 18. Of course, the SWD debug port18 can be used to upload other data and software into the memory 34.Once the necessary information is loaded on the PCBA 2 and finalprogramming is complete, the SWD debug port 18 can be removed viaperforations 19 before it is encased within the flexible material of themouth guard 1.

Because the high-G accelerometer 30 detects directional impact data, itis preferably located in a predictable reference point and, therefore,is mounted within the center tab 11 such that it is adjacent to themidline of the user's top incisors. Because its physical structure ismolded into the mouth guard 1 as discussed below in FIG. 6, the high-Gaccelerometer 30 maintains this same position along the centerline nearthe biting or incisive edge line of a maxillary central incisors. Insome embodiments with a user having an abnormal, or untraditional, mouthstructure regarding tooth placement, fillers may be used in the mouthguard 1 to fill in gaps between teeth (for instance additional materialto compensate for missing teeth, misplaced teeth, etc.). Preferably, theelectrical components and, in particular, the sensors (e.g., high-Gaccelerometer 30, magnetometer 31, and gyroscope 32) maintain directcontact with the structure of the mouth guard 1, which, in turn, ismolded to maintain direct contact with the skeletal structure and teethof the head. As such, the sensors maintain indirect (but rigid) contactwith the skeletal structure of the head. The sensors can also detect themovement and forces associated with the mouth guard 1 being dropped fromthe player's mouth or hand so as to discount such impact forces.

An LED driver 9 controls the actuation of an LED 10 on the front side 4of the PCBA 2. The LED 10 is used to indicate to others (e.g., otherplayers, a coach, a referee) that the user has experienced a certainconcussion-risk event (or events when considering a series of impactforces over a period of time). The LED 10 can also indicate operation(i.e., on/off), battery-charge life, malfunction, etc. The LED driver 9is located on front side 4 of PCBA 2 so that it can be viewed betweenthe user's lips. In a preferred embodiment, the LED driver 9 controlsboth the light intensity and the color of the LED 10 via the currentdriven into LED 10. By supplying a fixed current, the LED driver 9 canmodify that current to get the appropriate pattern of light(s) displayedon the LED 10 to indicate certain information to others located aroundthe user (and to the user when he or she removes the mouth guard 1 fromhis or her mouth).

The battery 22 typically supplies between 3 volts and 4.2 volts. Tomaintain adequate performance levels of components, a main voltageconverter 26 is used to provide a constant voltage to the components. Abattery charger 23, which is coupled to the wireless charging receiver20, preferably includes an integrated circuit to monitor and provide aspecific charging profile for the battery 22. The wireless coil 21receives alternating current, and converts it to direct current for thebattery 22. The wireless coil 21 preferably receives alternating currentat approximately one million hertz, or as otherwise known in the art.

The PCBA 2 includes a battery fuel gauge 24 near one of the end portions3. The battery fuel gauge 24 utilizes a Coloumb-countering feature and acomparative table to calibrate the charge remaining on the battery 22.The battery 22 typically operates in multiple modes, such as in a normaloperational mode, a charging mode, and a standby mode. The battery 22 ispreferably a Lithium polymer battery with a low-profile and an abilityto slightly bend during the manufacturing process (discussed in FIG. 6)to foster an ergonomic fit into the mouth guard 1. In one preferredembodiment, a gel electrolyte lithium battery is preferred, which mostpreferably uses a non-toxic electrolyte. While lithium polymer batteriesare preferred, as battery technology improves and/or changes, othertypes of batteries having a thin profile and a light weight (andpreferably the non-toxic nature of the electrolyte) will drive selectionof battery. A battery protection component 27 may be used to preventshorting of the battery via overcharging and/or undercharging. Thebattery protection 27 also prevents the battery 22 from running below aminimum charge. Because of the size of the battery 22 (length and heightdimensions), the battery 22 is located toward one of the end portions 3of the PCBA 2 in which there is more space between the buccal surfaceand the bone/teeth. Advantageously, the mouth guard 1 has a largerradius of curvature in this region as well, which results in lessbending of the battery 22.

The PCBA 2 includes a wearer notification component 36, preferablyadjacent to the end 3 of the PCBA 2. The notification component 36 useselectrical energy to generate mechanical energy to provide a hapticfeedback, a vibratory feedback (e.g., a buzzer), or an auditoryfeedback, which may be both heard by the ear and felt within the mouth.The notification component 26 may include magnetics and/or piezoelectricelements. Because of the generation of mechanical and/or audible energy,the notification component 36 may be one of the high-energy consumptioncomponents on the PCBA 2 (the LED 10 is often the highest energyconsuming component, depending on the size and functionality).Furthermore, the notification component 36 typically has the tallestprofile rising from the PCBA 2 and uses a fair amount ofthree-dimensional space extending off of the surface of the PCBA 2. Tocreate the most space for the notification component 36, thenotification component 36 is located toward the end portion 3 of thePCBA 2 in which there is more space between the buccal surface and thebone/teeth. The notification component 36 is preferably positioned onthe back side 6 of the PCBA 2 directly adjacent to the bone just belowthe maxillary sinus cavity to vibrate the bone and conduct vibrationsalong the maxilla toward the ear, which may provide a tonal sensationand/or an audible sensation (depending on the vibration frequency).

In other embodiments, the notification component 36 may use an airvibration conductor via a magnet and plate using compressed air.Alternatively, the notification component 36 may create haptic feedbackthrough motors using offsetting weights. Alternatively, the notificationcomponent 36 may include a linear resonant actuator (LRA) using a smallmetal block, or pin.

The notification component 36 is particularly useful to notify the userthat he or she has received a significant impact (or series of impacts)that he or she may not have recognized. For example, after a single,high-force impact creates a substantial risk of concussion, theprocessor 28 receives the data from the rotational and/or linear forcesensing units and determines whether the predetermined threshold hasbeen exceeded. If so, the processor 28 then communicates with thenotification component 36 to begin activation that results in the hapticfeedback, a vibratory feedback (e.g., a buzzer), or auditory feedback.In some embodiments, the processor 28 may delay the activation of thefeedback by a set period of time (e.g., 10 or 20 seconds) such that theuser has some time to regain full awareness after a big hit, so as tounderstand what the feedback is intended to mean. The notificationcomponent 36 can also provide different types of feedback (in duration,magnitude, or frequency) to inform the user of different events. Forexample, a series of lesser hits within a period of time that causes theseries-based threshold to be exceeded may have a different feedback(e.g., smaller magnitude and a lower frequency) than a single,high-force impact of the component (e.g., high magnitude and a highfrequency, or constant feedback). The notification component 36 can alsocommunicate other events, such as a low-battery mode or to remind theuser that system is operational, which may be accomplished in a singlesubtle feedback at a very low frequency (e.g., every 60 seconds).

As seen in FIGS. 1 and 2, the vast majority of the componentselectronics are within the middle portion 7 of the PCBA 2, but most areto the side of center tab 11 except for the LED 10 and the high-Gaccelerometer 30. Further, the vast majority of the sensitive electricalcomponents are on the back side 6 of the PCBA to allow them to beimpressed into the flexible material of the mouth guard 1 in a directionthat faces the teeth to give them added protection from impacts to theface. As noted above, the LED 10 is on the front side 4 so as to permitthe viewing of the LED 10 by other people around the user. The battery22 is likewise on the front side 4 of the PCBA 2 for spatial reasons.The charging coil 21 is on the front side 4 to provide better access forcharging the battery 22. FIGS. 1-2 represents one embodiment of thepresent invention and the components can be rearranged on the PCBA 2.

The width of the of the PCBA 2 (top-to-bottom) varies along the lengthand is between 2 mm and 15 mm, with the largest width being in the endregion 3 in the illustrated embodiment. The middle portion 7 has aheight in the range of 6 mm to 15 mm, and is preferably about 12 mm.Each of the end portions 3 having a width in the range of 8 mm to 15 mm.The bridge portions 16, 17 have a width that is smaller than 40% (andpreferably smaller than 30%) of the widths of the end portions 3. Thebridge portions 16, 17 have a width that is smaller than 50% (andpreferably smaller than 40%) of the width of the middle portion 7.

FIG. 3 is a general schematic in cross-section of one preferredembodiment for a flexible printed circuit board (PCB) 101 that wouldreceive the electrical components and form the PCBA 2. All layers areshown in FIG. 3, though not all of them are present across the entirePCB 101 as understood by those skilled in the art. Unlike prior artrigid PCBs that include foil stacked on glass or other rigid materials,the flexible PCB 101 is preferred as its shape may be modified and bentinto an ergonomic position, as discussed more in FIG. 6. The flexiblePCB 101 has multiple conductive layers, such as four metallic traces,that transit the signals between the electrical components. An upper andlower overlay surfaces 102 protect those internal layers, but would notpresent in areas when component soldering is required. Two solder-resistlayers 104 are located on the metallic (e.g. copper) trace 108 of theback side 6 (primary component side) and the metallic trace 110 on thefront side 4, at least in regions of the PCB 101 where componentsoldering is needed. The electrical working layers further include aground layer 112 and a power layer 114 (or signal and power layer 114).Each of the four metal layers 108, 110, 112, and 114 is about 0.02 mm inthickness (e.g., 0.018 mm or 0.022 mm).

The ground layer 112 and the power layer 114 is separated by adielectric layer 116, such as polyimide. The back side copper trace 108is separated from the power layer 114 by a dielectric layer 116 and anadhesive layer 118. The front side copper trace 110 is also separatedfrom the ground layer 112 by a dielectric layer 116 and an adhesivelayer 118. The dielectric layers 116 and adhesive layers 118 are eachabout 0.025 mm in thickness. The overall thickness of the PCB 101 isbetween about 0.2 mm and about 0.3 mm. The PCB 101 may include exteriorside tape on both the front side 4 and back side 6 in some regions,which is useful in mechanically attaching some of the larger components(e.g., the battery 22 and the charging coil 21) to the PCB 101.

FIGS. 4A and 4B illustrate the left side and right side cross-sectionsof the PCBA 2 along, respectively, lines 4A-4A and lines 4B-4B of FIG.1, both of which cut through the high-G accelerometer 30 on the backside 6 and the LED 10 on the front side 4. The dimension X-X refers tothe overall thickness of the printed circuit board, which is about 0.2mm in the illustrated embodiment. The dimension Z-Z in FIG. 4Areferences the height of the LED 10, which is about 0.6 mm. The battery22 shown in FIG. 4B has a height dimension W of about 2.0 mm. Thenotification component 36 shown in FIG. 4B also has a height dimension Uof about 2.0 mm. The charging coil 21 shown in FIG. 4A has a heightdimension of about 0.4 mm, which is less than the height dimension ofthe LED 10. One of the parts of the coil charging receiver 20 has aheight dimension Y-Y in FIG. 4 of about 1.2 mm. According, while theoverall PCBA 2 has a length of about 110 mm, the maximum overall heightdimension of the PCBA 2 (including components on the top side 4 and readside 6) is less than 5 mm in all regions, such that the ratio of lengthto overall height is greater than 20.

The end portion 3 with the battery 22 and notification component 36 mayhave a maximum overall height dimension of about 4.2 mm, and ispreferably less than 4 mm. In the middle portion 7, the maximum overallheight dimension at any point along the length is less than 2 mm (e.g.,1.8 mm), and is preferably less than 1.5 mm, which is dictated by thenearly overlaying the high-G accelerometer 30 on the back side 6 and theLED 10 on the front side 4. In the end portion 2 with the coil 21, themaximum overall height dimension is less than 2 mm (e.g., 1.9 mm), andis preferably less than 1.5 mm. The bridge portions 16, 17 of the PCBA 2that connect the end portions 3 and the middle portion 7 preferablyinclude no components and have a maximum dimension between about 0.2 mmto 0.3 mm, and preferably about 0.2 mm (i.e., the thickness of theprinted circuit board in FIG. 3) to provide additional flexibility (bothbendability and rotational twistability) to the overall PCBA 2, which ishelpful when manufacturing mouth guard 1 as shown in FIG. 6. FIGS. 4Aand 4B illustrate only one exemplary preferred embodiment of alow-profile PCBA 2 for use in the mouth guard 1, as other componentarrangements and configurations can be used.

FIG. 5 is one embodiment of a general schematic illustrating theconnectivity of the components mounted on the PCBA 2. The battery 22provides power to all of the various components. The processor moduleincludes the main processor 28 in communication with the components,receiving data (e.g., from the sensors) and sending communicationsinstructions (e.g., to the LED 10 and notification component 36). Theprocessor module may also contain the Bluetooth transceiver 29 thatallows for communication with one or more external devices, such as thesmart device 50 associated with of the user, a parent, a coach, areferee, etc. The smart device 50 would include the software (e.g., inthe form of an app) to receive and transmit information with theBluetooth transceiver 29 within the mouth guard 1 while in use orbefore/after use. The smart device 50 also provides remote storage,computation, and display of risk factors associated with one or moremouth guard devices. The smart device 50 may be smart phone, a tablet,or a computer. One exemplary smart device 50 is shown in FIG. 8. Othersystem configurations for the connectivity of the components of the PCBA2 are possible as well.

FIGS. 6A-6D illustrate a series of stages in developing the mouth guard1. A model 80 of the user's mouth, specifically of the maxillary regionteeth, is made. The model 80 may be created by a dental professional, byuse of an intra-oral scanner, or by use of a simple home impressiontray. As showing in FIGS. 6A-6D, the model 80 is a stone model that isformed within an impression that was impressed over the user's teeth andgingiva. The stone is poured into the impression to create the stonemodel 80, resulting in a replica of the user's upper teeth and bonestructure.

In one preferred embodiment shown in FIGS. 6A-6D, the method for formingthe wearable mouth guard 1 is performed as follows. As shown in FIG. 6A,the model 80 is placed upside down and inserted into a thermoformingmachine (e.g., a pressure thermoforming machine) that is designed toproduce custom mouth guards, such as a Drufomat® manufactured and soldby Dentsply Sirona. As shown in FIG. 6B, a first base layer 82 of about3 mm of EVA thermoplastic (other flexible materials are possible aswell) is placed over the model 80. Within the thermoforming machine, thefirst layer 82 is heated and thermoformed over the model 80 so that itwill substantially conform to the anatomical structures (e.g., bone,gingiva, teeth, etc.) of the maxillary region of the oral cavity ofuser, as dictated by the model 80. Due to the heat and pressure, theinitial thickness of the first layer 82 decreases by about 30% to 40%when overlaid onto the model 80. For example, when the first layer 82 of3 mm is used, the final thickness of the first layer 82 is approximately1.8 mm to 2.1 mm. The first layer 82 is then ready to receive the PCBA2. It should be noted that trimming and polishing may be performed onthe first layer 82, as necessary.

The PCBA 2 is tested and programmed prior to being molded into the baselayer 82. Once the PCBA 2 passes all tests and the latest firmware hasbeen programmed, the region with the SWD debug port 18 (FIGS. 1-2) istrimmed off using scissors along the perforations 19. By use of thedebug port 18, the memory 34 is programmed to include, for example, thespecific predetermined threshold data points based on the biometricinformation received from that particular user.

Once the programmed PCBA 2 is ready, a heat gun is employed to sweepacross and soften the first layer 82. In one embodiment, a 700 W heatgun with about 120 L/m of air flow is set to 350° C. and is used forabout 30 seconds to heat the material. With the first layer 82 nowsoftened, the PCBA 2 is placed with the back side 6 (and the majority ofthe electrical components) facing inward towards the softened firstlayer 82. The softening is not harsh enough to affect the conformance ofthe first layer 82 to the underlying model 80. For the first connectionpoint, the high-G accelerometer 30 on the central tab 11 (not shown inFIG. 6) is positioned directly adjacent to the midline of the twocentral incisors. The central tab 11 and physical structures of thehigh-G accelerometer 30 and adjacent components, such as the LED driver9 and the processor 28, on the rear side 6, are forced into anddepressed within the first layer 82. For vertical alignment, the edge ofthe middle portion 7 closest to the LED 10 should be aligned with thecutting edges of the replica incisors within the model 80. Next, theremainder of the components on the rear side 6 of the middle portion 7are impressed into the softened first layer 82.

After the components of the middle portion 7 are impressed within thefirst layer 82, the remaining portions of the left side and right sideof the PCBA 2 are depressed into the first layer 82, including allcomponents (e.g., wireless charging components 20 and the notificationcomponent 36) near the two end portions 3. Typically, the heat gun maybe needed again to soften the first layer 82 along its sides toaccommodate those materials. The bridge portions 16, 17 of the PCBA 2provide the bending and twisting needed to accommodate the wide varietyof anatomic variations in the maxilla region of the general population.As shown in FIG. 6C, the PCBA 2 is fixed into the first layer 82 byimpressing the geometric arrangement of the electrical components on theback side 6 of the PCBA 2 into the softened first layer 82. The LED 10,the battery 21, and the charging coil 21 are mounted to the front side 4of the PCBA 2 and, thus, project outwardly away from the underlyingmodel 80.

Because of the unique shape of the model 80 due to each user's uniqueanatomy, the PCBA 2 will fit a bit differently on the first layer 82 foreach user. Accordingly, a deformable filler material, such as Fillin™from Dreve Dentamid GmbH, is provided to fill in the small gaps betweenthe back side 6 of the PCBA 2 and the first layer 82, and also betweenthe first layer 82 and some of the larger inwardly-facing (tooth-facing)components, such as the wireless charging components 20 and thenotification component 36. This deformable material is similar to a waxsuch that it can be rolled into thin pieces and shaped as necessary.Additionally, the deformable filler material is used to smooth any roughsurfaces (like the corners of the battery 22 or the coil 21) to preventunnecessary pressure points for the next layer. This helps to eliminategaps between the PCBA 2 (and the fronts-side electrical components) andthe base layer 82, which may permit air to become trapped when thesecond layer 84 (e.g. EVA) is applied. In other words, the deformablefiller material is used to fill in gaps and smoothen sharp corners for amore reliable placement of the second layer 84. The deformable fillermaterial can also be type of hot glue, such as EVA.

As shown in FIG. 6D, the second layer 84 is placed over the combinationof the first layer 82 and the PCBA 2 (and any Fillin™ material) withinthe thermoforming machine, to allow pressure molding of the second layer84 over the PCBA 2. The heated second layer 84 is formed to fit over theLED 10, the battery 22, and the charging coil 21 on the front side 4 ofthe PCBA 2. The second layer 84 can be anywhere from 1 mm to 4 mm and,like the first layer 82, becomes thinner (and denser) upon applicationof heat and pressure. Assuming a 2 mm final thickness of the first layer82, a second layer 84 of 1 mm creates about 3-4 mm thickness across mostof the mouth guard 1, which may be more appropriate for sports likebiking, basketball, etc. Assuming a 2 mm final thickness of the firstlayer 82, a second layer 84 of 4 mm creates about a 4-5 mm thicknessacross most of the mouth guard 1, which may be more appropriate fordirect impact sports, such as boxing or football. The thickness of thesecond layer 84 depends in part on user preference, and the requirementfor safe functionality. Trimming and polishing can be performed afterthe second layer 84 has been added to the first layer 82 and PCBA 2.

The total thickness, of course, varies a bit over the regions of themouth guard 1 due to the electrical components on the PCBA 2. Forexample, in the front portion 92 (FIG. 7) of the mouth guard 1 having anarch-shaped surface 94 (FIG. 7) exposed to the buccal surface, the endportion 3 of the PCBA 2 having the battery 22 and notification component36 will have the greatest localized thickness of the overall mouth guard1, with a thickness less than 7 mm, and preferably less than 6 mm. Inthe front portion 92 of the mouth guard 1 exposed to the buccal surfaceand near the middle portion 7 of the PCBA 2 (with the majority of thecomponents), the maximum localized thickness of the mouth guard 1 willbe less than 5 mm, preferably less than 4 mm. In the front portion 92 ofthe mouth guard 1 exposed to the buccal surface near the other endportion 3 of the PCBA 2 having the charging coil 21 and wirelesscharging components 20, the maximum localized thickness of the mouthguard 1 will be less than 5 mm, preferably less than 4 mm. Between thesethree regions, the thickness in the bridge portions 16, 17 be less than4 mm, or less than 3 mm.

In one example illustrating the thickness of the front portion 92 of themouth guard 1 that faces the buccal region of the user's mouth, with thefirst layer 82 being 3 mm in thickness and the second layer 84 being 2mm in thickness, the end portion 3 with the battery 22 has a maximumthickness of about 5.5 mm, the middle portion 7 has a maximum thicknessof about 3.0 mm, and the end portion 3 with the charging coil 21 has amaximum thickness of about 3.3 mm. In a second example illustrating thethickness of the front portion 92 of the mouth guard 1, with the firstlayer 82 being 3 mm in thickness and the second layer 84 being 3 mm inthickness, the end portion 3 with the battery 22 has a maximum thicknessof about 6.1 mm, the middle portion 7 has a maximum thickness of about3.7 mm, and the end portion 3 with the charging coil 21 has a maximumthickness of about 4.0 mm

The overall thickness of the mouth guard 1 should not necessarily impactthe data measured, but can be compensated for by algorithms or softwarewhen programming the processor 28 for the predetermined thresholdlevels. For example, when additional thickness of the mouth guard 1 isused, it dampens the measured impact force. In other words, the mouthguard 1 is effectively reducing the amount of impact/force on the skulland brain by a small amount.

FIG. 7 demonstrates the finished mouth guard 1 produced by themanufacturing process of FIG. 6. The mouth guard 1 includes a main bodyhaving the arched-shaped peripheral side surface 90 on its front portion92 that generally follows the contour of the user's dental arch in themaxilla region. The front portion 92, which is comprised of the layeringof the first layer 82, the PCBA 2, and the second layer 84, includes theelectronic components. While most of those electronic components arefacing inwardly toward the teeth (and not seen in FIG. 7), but the LED10 faces the buccal direction and can be seen through the second layer84 of plastic. The charging coil 21 is also seen on the front side 4 ofthe PCBA 2. The center tab 11 that receives the high-G accelerometer 30is positioned in a location that is substantially aligned with themidline of the upper incisors of the user. The mouth guard includes anarch-shaped depressed portion 94 connected to the front portion 92 thatis sized and shaped to receive teeth of the user to help retain themouth guard in a fixed position in the mouth. A palate portion 96 of themouth guard 1 engages the roof of the mouth. Given the drive to producea device that minimizes the size, permits accurate data collection, andprovides user comfort, the mouth guard 1 of the present invention worksbetter with the aforementioned forming process. Though it is possible touse a mouth guard created from a one-size-fits-all approach (such asboil-and-bite mouth guards) with the present invention, theaforementioned forming process is the preferred method of manufacturing.

The first layer 82 can be made of a clear or colored material. Thesecond layer 84 is preferably clear in the region of the LED 10 so thatit can be observed by others, but other regions of the second layer 84can be colored. If no LED 10 is present in the mouth guard 1, then bothlayers 82 and 84 can be colored and opaque.

As shown in FIG. 8, a remote receiver in the smart device 50 may actwith a local app (e.g., software application) to receive and displayreal-time data or information from the mouth guard(s) 1 via thecommunication system (e.g., Bluetooth transceiver 29). Preferably, theremote smart device 50 includes a display 52 that permits the displayingof certain types of impact information from a specific mouth guard 1associated with a user (or multiple mouth guards from several users).For example, the display 52 may include a relative time indicator 54that may demonstrate the timing of a recent impact event. Furthermore,the display 52 may include impact data 56, such as acceleration andforce (linear and/or rotational). Further, a risk calculation 58 may bedisplayed. The risk calculation may be determined either locally orremotely, and is based predetermined impact thresholds unique to eachuser based on his or her biometric information. The risk calculation canalso be dynamically generated in that it is based on series of impactswithin a certain period of time. Accordingly, the present inventioncontemplates that when the mouth guard 1 senses a force exceeding acertain threshold, there are multiple options for notifications: (i) tothe user via the feedback from the notification component 36, (ii) toother individuals near the user via the LED 10, and (iii) tomore-remotely situated individuals via the display 52 of the smartdevice 50.

As noted above, the smart device 50 also permits the user to communicatewith the mouth guard 1. For example, the user can use the smart device50 to select his or her activity for the day such that processor 28 thenselects the corresponding impact force threshold data for thatparticular activity. The user can use the smart device 50 to indicatethe occurrence of a prior concussion, such that processor 28 thenselects a reduced impact threshold data. Or, in another alternative, theuser can dictate the reduced value of the impact threshold by indicatinga specific percent reduction in the threshold if he or she desires to benotified of lesser hits to stay far away from injury. The smart device50 may, in response to the user's command, download force data frommemory 34 on the PCBA 2, and then send instruction to erase the priorforce data or segments of the prior force data.

The smart device 50 is preferably in communication with a remote storage(e.g., the cloud) that contains the various types of threshold data forall users or a subset of users (e.g., football players). As better andmore precise threshold data is learned and stored in the remote storage,the smart device 50 downloads that updated data, which can then betransmitted to the user's mouth guard 1 via the Bluetooth connection. Inanother example, if the user decides to try another activity, such asrugby, the smart device 50 can download the rugby threshold data fromthe remote storage and then transmit that rugby threshold data to thecustomized mouth guard 1 for that user.

These embodiments and obvious variations thereof is contemplated asfalling within the spirit and scope of the claimed invention, which isset forth in the following claims. Moreover, the present conceptsexpressly include any and all combinations and subcombinations of thepreceding elements and aspects.

We claim:
 1. A method for manufacturing a custom mouth guard that detects impact forces of a user, comprising: conforming a first layer of material to a model of the user's maxillary region that includes replicated teeth; while the first layer of material is on the model and after the conforming, heating the first layer of material; forcing a flexible printed circuit board into the heated first layer to force a plurality of components extending away from the flexible printed circuit board to be impressed into the first layer, the flexible printed circuit board including linear and rotational force sensors; adding deformable material to gaps between the flexible printed circuit board and the first layer; overlaying a second layer of material over the flexible printed circuit board, the first layer, and the deformable material; and conforming the second layer of material to exposed surfaces of the flexible printed circuit board and the first layer to create the custom mouth guard.
 2. The method of claim 1, wherein the forcing the flexible printed circuit board includes (i) initially forcing an electrical component into the first layer at a location aligned with the central incisors to set the location for the printed circuit board and (ii) subsequently forcing other components into the first layer at locations closer to the molars.
 3. The method of claim 1, wherein both acts of conforming occur though a pressure thermoforming machine.
 4. The method of claim 1, after conforming the second layer, trimming or polishing the overall structure to create the final custom mouth guard.
 5. The method of claim 1, further including, before overlaying the second layer of material, adding additional deformable material along sides of electrical components mounted to an exposed outer surface of the flexible printed circuit board.
 6. The method of claim 1, wherein the heating includes using a heating gun to blow heated air across an exposed surface of the first layer.
 7. The method of claim 1, wherein the custom mouth guard includes a front portion with a generally arched-shaped peripheral side for facing the buccal region of a mouth of a user, the flexible printed circuit board being located between the first layer and the second layer in the front portion, the maximum thickness of the front portion being less than 7 mm.
 8. The method of claim 7, wherein the front portion of the custom mouth guard includes a central section for being adjacent to the central incisors, the linear and rotational force sensors being mounted on a middle portion of the flexible printed circuit board that is positioned within the central section, the central section having a maximum thickness of less than 4 mm.
 9. The method of claim 8, wherein the maximum diameter of the front portion is between 5 mm and 6 mm and is located over a battery mounted on the flexible printed circuit.
 10. A method for manufacturing a custom mouth guard that detects impact forces of a user, comprising: receiving biometric information associated with the user; storing impact threshold data on a memory of a flexible printed circuit board, the impact threshold data being based on the biometric information; after the receiving and the storing, conforming a first layer of material to a model of the user's maxillary region that includes replicated teeth; forcing the flexible printed circuit board into the first layer to impress electrical components on the flexible printed circuit board into the first layer; and conforming the second layer of material to exposed surfaces of the flexible printed circuit board and the first layer to create the custom mouth guard.
 11. The method of claim 10, wherein both acts of conforming occur though a pressure thermoforming machine.
 12. The method of claim 10, wherein the biometric information includes at least age, sex, and weight.
 13. The method of claim 12, further including, after the storing, removing a port section from the flexible printed circuit board to reduce an overall size of the flexible printed circuit board.
 14. The method of claim 10, wherein a middle portion of the flexible printed circuit board has a length that is between about 25% and 50% of the overall length of the flexible printed circuit board, the middle portion including two cut-outs to enhance the bendability of the flexible printed circuit board, the two cut-outs defining a central tab of the flexible printed circuit board.
 15. The method of claim 14, wherein the force sensor is mounted to a back side of the flexible printed circuit board within the central tab, and the forcing the flexible printed circuit board into the first layer impresses the force sensor into the first later.
 16. The method of claim 15, wherein a light indicator is located on a front side of the flexible printed circuit board and is impressed into the second layer.
 17. A method for manufacturing a custom mouth guard that detects impact forces of a user, comprising: receiving a stone model of the user's maxillary region that includes replicated teeth; receiving biometric information for the user, the biometric information at least including the age and sex of the user; determining impact threshold data for the user based on the biometric information; uploading the impact threshold data onto a memory device that is mounted on a flexible printed circuit board, the flexible printed circuit board having other components mounted thereon including a linear force sensor, a rotational force sensor, a processor, and a battery; conforming a first layer of material to the stone model of the user's maxillary region; while the first layer of material is on the model and after the conforming, heating the first layer of material; forcing the flexible printed circuit board into the heated first layer to force a plurality of the components from the flexible printed circuit board to be impressed into the heated first layer; and conforming a second layer of material to exposed surfaces of the flexible printed circuit board and the first layer, the conforming including impressing some of the components on the printed circuit board into the second layer of material.
 18. The method of claim 17, wherein the battery is one of the components on the printed circuit board that is impressed into the second layer of material.
 19. The method of claim 17, wherein the custom mouth guard includes a front portion with a generally arched-shaped peripheral side for facing the buccal region of a mouth of a user, the flexible printed circuit board being located between the first layer and the second layer in the front portion, the maximum thickness of the front portion being less than 7 mm.
 20. A method for manufacturing a custom mouth guard that detects impact forces of a user, comprising: conforming a first layer of material to a model of the user's maxillary region that includes replicated teeth; while the first layer of material is on the model and after the conforming, heating the first layer of material; forcing a flexible printed circuit board into the heated first layer to force a plurality of components extending away from the flexible printed circuit board to be impressed into the first layer, the flexible printed circuit board including linear and rotational force sensors; adding deformable material along sides of electrical components mounted to an exposed outer surface of the flexible printed circuit board; overlaying a second layer of material over the flexible printed circuit board and the first layer; and conforming the second layer of material to exposed surfaces of the flexible printed circuit board and the first layer to create the custom mouth guard. 